MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL; MPACT 3D METAL SHELL TWO HOLE Ø56MM

Model Number	01.38.056DH
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2026: lot 2318014: (b)(4) items manufactured and released on 13-sep-2023.No anomalies found related to the problem.To date, no similar events have been reported on the same lot during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had hip instability due to implant migration.The surgeon observed that the acetabular component did not have any boney growth and migrated superiorly and medially with a slight protrusion.At about 1 year and 6 months post op the surgeon revised all the acetabular components, head, and liner to a larger size for stability.The surgery was completed successfully.

• Brand Name: MPACT 3D METAL
• Common Device Name: MPACT 3D METAL SHELL TWO HOLE Ø56MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24454907
• Report Number: 3005180920-2026-00132
• Device Sequence Number: 13274725
• Product Code: LPH
• UDI-Device Identifier: 07630030812613
• UDI-Public: 07630030812613
• Combination Product (Y/N): N
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.38.056DH
• Device Lot Number: 2318014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male